Recruiting

Behavior Analytic Intervention

Sponsor:

Boston Medical Center

Code:

NCT06712784

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

Treatment Package (for both simulation and procedure sessions

Study Details

Brief summary:

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC).

A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.

Conditions

Autism Spectrum Disorder

Study ID

NCT06712784

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Caregivers of autistic patients who have been historically engaged in challenging behaviors during needle-related procedures at a Boston Medical Center (BMC)
  • Established BMC autistic patients (ages 3+) who have a history of engaging in challenging behaviors in the presence of needle-related medical stimuli.
  • BMC Medical Providers (i.e., phlebotomists, medical doctors, registered nurses, certified nursing assistants, registered dieticians, and medical assistants) who either: 1) order needle-related medical procedures for participants to be conducted during procedure visits and/or 2) are present to conduct the ordered procedure
  • English speaking participants

Exclusion Criteria:

  • Patients who are unable to visit BMC a minimum of 2 times per month
  • No history of challenging behaviors in medical appointments involving the presentation of needle(s)
  • Patients and caregivers who do not speak English or are unable to utilize interpreter services to complete assessments and surveys

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Packet

3-5 autistic BMC patients who have a history of engaging in challenging behaviors during needle-related procedures who are able to attend simulation sessions at BMC at least 2 times per month. A caregiver and clinician will also be recruited for each child participant.

Interventions

Treatment Package (for both simulation and procedure sessions

Treatment Package for both simulation and procedure sessions will include visit priming (contingency specifying stimuli in the form of social stories and YouTube videos) and differential reinforcement of alternative behavior (DRA).

Primary outcome measure

  • Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles) [ Time Frame: Baseline, on average 4 months ]
  • Number of task list steps completed in the absence of challenging behaviors [ Time Frame: Baseline, on average 4 months ]

Central Contacts and Locations

Central contacts

Jacqueline McKendry, MS BCBA LABA

617 414 3874jacqueline.mckendry@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Jacqueline McKendry, MS BCBA LABA

617-414-3874jacqueline.mckendry@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Behavior analytic research
  • Needle-related healthcare visits
  • Simulation visits
  • Differential reinforcement of alternative behavior (DRA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-07-09.